HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site

HEAL Initiative：新生儿阿片类药物戒断综合征药物治疗效果比较试验新墨西哥州网站

• 批准号: 10378942
• 负责人: LAWRENCE M LEEMAN
• 金额: $ 44.54万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378942
• 关键词: Admission activity; Age-Months; Assessment tool; Buprenorphine; Caring; Development; Dose; Drug Exposure; Ensure; Evaluation; Growth; Health Benefit; Helping to End Addiction Long-term; Hospitals; Infant; Institution; Latinx; Length; Length of Stay; Methadone; Methamphetamine; Mexican; Morphine; Mothers; Native Americans; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; New Mexico; Newborn Infant; Nurseries; Nursing Research; Outcome; Outcome Measure; Perinatal; Pharmaceutical Preparations; Pharmacological Treatment; Population; Principal Investigator; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Regimen; Research; Research Personnel; Research Subjects; Selective Serotonin Reuptake Inhibitor; Series; Site; Standardization; Time; Tobacco use; Toddler; Treatment Cost; Universities; Weaning; Woman; clinical center; clinically relevant; comparative effectiveness; comparative effectiveness study; comparative effectiveness trial; design; experience; follow-up; improved; maternal opioid use; multi-ethnic; neonatal care; neonate; neurodevelopment; non-opioid analgesic; opioid epidemic; opioid use; opioid use disorder; optimal treatments; polysubstance use; recruit; study population

Project Summary/Abstract The Neonatal Opioid Withdrawal Syndrome (NOWS) Pharmacological Treatments Comparative Effectiveness Trial is a multisite study that examine the long- and short-term outcomes for neonates with NOWS that require pharmacological treatment. The neonates will be randomized to three medications: buprenorphine, methadone and morphine. Short term outcomes are anticipated to include length of hospital stay and length of pharmacological treatment, with longer term outcomes including neonatal growth and neurodevelopment. The common protocol will be developed by a steering committee composed of the principal investigators from each participating clinical center. The trial will be designed to control for relevant clinical variables including the type of maternal opioid used, maternal polysubstance use including tobacco, the use of nonpharmacological treatments for NOWS, and the use of adjunctive nonopioid medications. The follow-up plan will be developed as part of the protocol and will extend until at least 24 months of age and include the use of specific neurodevelopmental assessment tools including the Bayley Scales of Infant and Toddler Development 4th Edition. The trial is designed to determine the optimal pharmacological treatment including the specific medication dosing and weaning regimen. The University of New Mexico Clinical Center will include infants treated for NOWS across all neonatal care sites including the mother baby unit where dyadic room-in care is provided, the intermediate care nursery, and the neonatal intensive care unit. The standardization of pharmacological treatment for NOWS is anticipated to have significant public health benefits including decreasing length of hospital stay, decreasing cost of treatment, and potentially improving long term neurodevelopmental outcomes.

项目概要/摘要 新生儿阿片类药物戒断综合征 (NOWS) 药物治疗比较 有效性试验是一项多中心研究，旨在检查新生儿的长期和短期结果 现在需要药物治疗。新生儿将被随机分配使用三种药物： 丁丙诺啡、美沙酮和吗啡。预计短期结果包括住院时间 药物治疗的停留时间和长度，以及长期结果，包括新生儿生长和 神经发育。共同协议将由指导委员会制定，该委员会由 来自每个参与临床中心的主要研究人员。该试验旨在控制相关 临床变量，包括母亲使用的阿片类药物的类型、母亲使用多种物质（包括烟草）、 对NOWS 使用非药物治疗，以及使用辅助非阿片类药物。这 后续计划将作为方案的一部分制定，并将持续到至少 24 个月大，并且 包括使用特定的神经发育评估工具，包括婴儿贝利量表和 幼儿发展第四版。该试验旨在确定最佳药物治疗 包括具体的药物剂量和断药方案。新墨西哥大学临床中心 将包括所有新生儿护理场所接受 NOWS 治疗的婴儿，其中包括母婴病房 提供二元病房护理、中间护理托儿所和新生儿重症监护病房。这 NOWS 药物治疗的标准化预计将对公共卫生产生重大影响 好处包括缩短住院时间、降低治疗费用以及潜在的改善 长期神经发育结果。